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Blood, 15 August 2005, Vol. 106, No. 4, pp. 1183-1188. Prepublished online as a Blood First Edition Paper on May 10, 2005; DOI 10.1182/blood-2004-10-3821. This Article Full Text Full Text (PDF) All Versions of this Article: 2004-10-3821v1 106/4/1183    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Arceci, R. J. Articles by Sievers, E. L. Search for Related Content PubMed PubMed Citation Articles by Arceci, R. J. Articles by Sievers, E. L. Related Collections Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS Safety and efficacy of gemtuzumab ozogamicin in pediatric patients with advanced CD33+ acute myeloid leukemia Robert J. Arceci, Jane Sande, Beverly Lange, Kevin Shannon, Janet Franklin, Raymond Hutchinson, Terry A. Vik, David Flowers, Richard Aplenc, Mark S. Berger, Matthew L. Sherman, Franklin O. Smith, Irwin Bernstein, and Eric L. Sievers From the Cincinnati Children's Hospital Medical Center, Cincinnati, OH; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Children's Hospital of Philadelphia, Philadelphia, PA; University of California at San Francisco, CA; Children's Hospital of Los Angeles, CA; C.S. Mott Children's Hospital, University of Michigan, Ann Arbor; James Whitcomb Riley Hospital for Children, Indiana University School of Medicine, Indianapolis; Fred Hutchinson Cancer Research Center, Seattle, WA; Wyeth Pharmaceuticals, Philadelphia, PA; and University of Washington, Seattle. This open-label, dose-escalation study evaluated the safety and efficacy of single-agent gemtuzumab ozogamicin, a humanized anti-CD33 antibody–targeted chemotherapeutic agent, for pediatric patients with multiple relapsed or primary refractory acute myeloid leukemia (AML). Twenty-nine children 1 to 16 years of age (relapsed disease, 19; refractory disease, 10) received gemtuzumab ozogamicin ranging from 6 to 9 mg/m2 per dose for 2 doses (separated by 2 weeks) infused over 2 hours. All patients had anticipated myelosuppression. Other toxicities included grade 3/4 hyperbilirubinemia (7%) and elevated hepatic transaminase levels (21%); the incidence of grade 3/4 mucositis (3%) or sepsis (24%) was relatively low. One patient treated at 9 mg/m2 developed veno-occlusive disease (VOD) of the liver and defined the dose-limiting toxicity. Thirteen patients underwent hematopoietic stem-cell transplantation less than 3.5 months after the last dose of gemtuzumab ozogamicin; 6 (40%) developed VOD. Eight of 29 (28%) patients achieved overall remission. Remissions were comparable in patients with refractory (30%) and relapsed (26%) disease. Mean multidrug resistance-protein–mediated drug efflux was significantly lower in the leukemic blasts of patients achieving remission (P < .005). Gemtuzumab ozogamicin was relatively well tolerated at 6 mg/m2 for 2 doses and was equally effective in patients with refractory and relapsed disease. Further studies in combination with standard induction therapy for childhood AML are warranted. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: R. Aplenc, T. A. Alonzo, R. B. Gerbing, B. J. Lange, C. A. Hurwitz, R. J. Wells, I. Bernstein, P. Buckley, K. Krimmel, F. O. Smith, et al. Safety and Efficacy of Gemtuzumab Ozogamicin in Combination With Chemotherapy for Pediatric Acute Myeloid Leukemia: A Report From The Children's Oncology Group J. Clin. Oncol., May 10, 2008; 26(14): 2390 - 2395. [Abstract] [Full Text] [PDF] R. M. Sharkey and D. M. Goldenberg Targeted Therapy of Cancer: New Prospects for Antibodies and Immunoconjugates CA Cancer J Clin, July 1, 2006; 56(4): 226 - 243. [Abstract] [Full Text] [PDF] E. Roman, E. Cooney, L. Harrison, O. Militano, K. Wolownik, R. Hawks, S. Foley, P. Satwani, E. Unal, M. Bhatia, et al. Preliminary Results of the Safety of Immunotherapy with Gemtuzumab Ozogamicin following Reduced Intensity Allogeneic Stem Cell Transplant in Children with CD33+ Acute Myeloid Leukemia Clin. Cancer Res., October 1, 2005; 11(19): 7164s - 7170s. [Abstract] [Full Text] [PDF]

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